CN114945401B - drug infusion device - Google Patents
drug infusion device Download PDFInfo
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- CN114945401B CN114945401B CN202080092593.2A CN202080092593A CN114945401B CN 114945401 B CN114945401 B CN 114945401B CN 202080092593 A CN202080092593 A CN 202080092593A CN 114945401 B CN114945401 B CN 114945401B
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- drug infusion
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M2039/0205—Access sites for injecting media
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/025—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body through bones or teeth, e.g. through the skull
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/027—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body having a particular valve, seal or septum
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/0282—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body with implanted tubes connected to the port
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/06—Head
- A61M2210/0693—Brain, cerebrum
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
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Abstract
A drug infusion device for implantation between the skull and scalp of a patient and for infusion of a drug is disclosed. The disclosed drug infusion device comprises: a body connected to the skull and fixed by implantation, and having an internal hole formed therein; a body fixing part formed with an inner hole adjacent to the body to be combined and fixed in a manner of facing the body and fastened; a movable part located between the body and the body fixing part, and having a medicine injection hole formed at the center, capable of switching the direction to a target place; a sealing part provided in a form of sealing the medicine injection hole of the movable part for insertion of an injection needle for injecting medicine; a movable cover part which is positioned at the upper part of the sealing part, seals and fixes the movable part, blocks the sealing part in a form of preventing the sealing part from separating from the outside, identifies the implantation position of the drug injection device, and guides the repeated application place; and at least two fastening connection parts for fastening the upper parts of the body and the body fixing part to the skull, wherein the body comprises a supporting part positioned on the upper part of the skull and supported, the outer diameter of the supporting part is smaller than that of the body fixing part and larger than that of the movable part, and the two fastening connection parts are combined in a mode of being adjacent to the body fixing part, so that the movable part is accommodated and fixed in the inner hole of the body.
Description
Technical Field
The present invention relates to a drug injection device that can be used in a more accurate position by providing an intra-brain drug injection device for repeated drug administration in the long term in the skull of a patient having a brain nerve disease such as obesity, cerebral apoplexy, spinal nerve, dementia, etc.
Background
Recently, diseases that have decreased quality of life, particularly brain-related diseases that have increased socioeconomic costs, have become a number of social issues. Brain-related diseases, such as degenerative brain diseases, mental system diseases, brain tumors, cerebral strokes, obesity, cerebral strokes, spinal nerves, etc., are increasing each year. In the case of end-stage cancer and chronic pain patients suffering from brain diseases, pain is relieved by continuous and repeated administration of analgesics. In addition, in the case of dementia patients suffering from degenerative brain diseases such as Alzheimer's disease or mental diseases such as Parkinson's disease, it is necessary to continuously and repeatedly administer therapeutic agents such as chemotherapeutics and stem cells in order to maximize therapeutic effects.
In order to improve the therapeutic effect of brain-related diseases, methods of treatment by repeated oral administration and intravenous administration for a long period of time are currently used in many cases. However, the conventional methods are limited in that, in the case where the digestive organs are weakened, it may be difficult to take medicines themselves, side effects may be induced due to systemic circulation of the therapeutic agent, and physical pain and economic burden of the patient due to admission therapy, administration of the therapeutic agent, and the like are also great.
In addition, the method of administering drugs directly to the brain has an effect superior to that of the existing methods, and on the other hand has an advantage in that there are few side effects caused by systemic circulation of the drugs. For example, in the case of a patient suffering from dementia, a therapeutic agent such as a chemical drug or stem cells can be directly administered to a target site, which is the sea horse body (Hippocampus). However, the difficulty is that Brain-targeted drugs must cross the Blood-Brain Barrier (BBB). In order to improve the therapeutic effect, it is necessary to repeatedly apply the drug to an accurate target site.
Accordingly, the prior art has developed drug infusion devices that are implanted in the brain for a long period of time and repeatedly administered to an accurate target site. However, since the guide tube is inserted in a different position or in only one direction, the medicine cannot be newly introduced into the accurate position, and thus there is a limitation in that the accuracy of the operation is lowered. In particular, there is a limitation in that when the drug is repeatedly administered to a lesion such as the inside of the brain parenchyma, the accuracy of the guide tube is lowered, and in the case where the drug injection device implantation operation is required repeatedly, the economic cost burden of the patient is increased, and the satisfactory therapeutic effect is reduced.
Disclosure of Invention
The present invention has been made in view of the above-described problems, and an object of the present invention is to provide a drug injection device capable of being directly injected into the brain, and being used for treating brain diseases such as obesity, cerebral stroke, spinal nerves, and the like, in addition to dementia, so that a guide tube of the drug injection device can be accurately positioned close to a focus, i.e., a target site, and can be changed in direction with reference to a central axis.
Another object of the present invention is to provide a drug infusion device that can easily identify a site of implantation and repeatedly infuse a drug into the site even if the site is incised without performing a general anesthesia surgical operation when repeatedly infusing the drug.
Still another object of the present invention is to provide a drug infusion device in which the outside of the skull and the inside of the brain parenchyma are doubly blocked by the sealing part and the movable cover part, thereby preventing the backflow of drugs and the invasion of external pollutants due to repeated administration.
In order to achieve the object, a drug injection device for injecting a drug as a transplant fixed between a skull and scalp of a patient, comprising: a body connected to the skull and fixed by implantation, and having an internal hole formed therein; a body fixing part formed with an inner hole adjacent to the body to be combined and fixed in a manner of facing the body and fastened; a movable part located between the body and the body fixing part, and having a medicine injection hole formed at the center, capable of switching the direction to a target place; a sealing part provided in a form of sealing the medicine injection hole of the movable part for insertion of an injection needle for injecting medicine; a movable cover part which is positioned at the upper part of the sealing part, seals and fixes the movable part, blocks the sealing part in a form of preventing the sealing part from separating from the outside, identifies the implantation position of the drug injection device, and guides the repeated application place; and at least two fastening connection parts for fastening the upper parts of the body and the body fixing part to the skull, wherein the body comprises a supporting part positioned on the upper part of the skull and supported, the outer diameter of the supporting part is smaller than that of the body fixing part and larger than that of the movable part, and the movable part is combined in a mode of being adjacent to the body fixing part, so that the movable part is accommodated and fixed in the inner hole of the body.
The drug infusion device may further comprise: and a guide tube connected to the movable portion, inserted into the ventricle and positioned close to the target, and guiding an injection needle for injecting a drug into the target site in the target direction.
The guide tube may further include: and a tube connecting part arranged at the lower end of the medicine injection hole and connected between the movable part and the guide tube, wherein a hole connected with the inside of the guide tube is formed inside the tube connecting part.
The support portion is located at the upper portion of the body and may include: at least one first fastening connection hole for fixing in a form in which the fastening connection part is inserted and prevented from moving; and at least one fixing protrusion which is fixed in a form of being combined with the body fixing part.
The body fixing part may include: a recognition part, the upper part of which protrudes into a curved surface, for recognizing the implantation position of the drug injection device; a fixing hole which fixes the outside in a form of preventing the movable part from moving at the center; at least one second fastening connection hole fixed at an upper circumference in such a manner that the fastening connection part is inserted and prevented from moving; the lower part of the combining groove is concavely formed into a curved surface, and is consistent with the shape of the supporting part of the body, so that the combining groove is easy to combine; and at least one fixing groove coupled inside the coupling groove in a form facing the fixing protrusion.
The movable part includes: and a movable body part which is positioned in the movable accommodating hole, has a curved shape and can change the direction, and can be provided with a medicine injection hole which is hollow in the center and guides medicine to be injected into the target site.
The medicine injection hole may include: a first housing portion for housing a seal portion located in the inner hole of the movable portion; and a second housing part connected to the first housing part and located at the lower end of the inside of the movable part, and housing the guide tube and the injection needle inserted at the time of drug injection.
The first housing portion may be formed as a screw thread from the start point of the movable portion inner hole to the point of housing the seal portion.
The movable portion may be formed in a spherical shape composed of sphericity of less than 0.03 mm.
The sealing portion may be composed of a silicone material.
The movable cover part may include: a cover upper end part which is positioned outside the movable part and internally comprises a needle accommodating part, wherein a hole which is inclined downwards is formed in the center, namely the needle accommodating part is formed in the center so as to inject the injection needle; and a cap fastening part connected to the cap upper end, the exterior of which is formed with a screw thread, and the medicine injection hole is fastened and connected with the screw thread constituting the male and female.
The fastening connection part includes: a main body part for vertically fixing at least one of the main body and the main body fixing part in the skull; and a head portion provided in a form connected to the body portion; the head may include: a horizontal groove which is positioned at the center and is fastened and connected with a fastening and connecting tool horizontally during fastening and connecting; and a recognition groove which is formed in a line shape divided into a horizontal axis and a vertical axis based on the horizontal groove and can be recognized.
The body portion is fixed upright in the cranium, is threaded in a tapered form up to the tip, and may be formed with at least one relief groove.
The guide tube is formed with at least one medicine insertion hole so that medicine flows instead of accumulating on one side or both sides, and inner and outer diameters of the distal end of the guide tube may be formed in a curve having a shape minimizing tissue damage when inserted into the cranium.
At least any one of the body, the body fixing portion, the movable cover portion, and the guide tube of the drug infusion device may be composed of polyether ether ketone.
The fastening connection member may be composed of a titanium material.
The sealing part further comprises a filter which prevents foreign matters from being put into the inside, and can comprise an integrated sealing filter membrane, so that the filter and the sealing part are integrated, and the disposable replacement and the arrangement are easy.
The guide tube is rotated and deformed in the direction of the target point on the left and right sides from the central axis by a maximum angle of 60 DEG or less with reference to the surface in contact with the skull.
The drug injection device according to the present invention has an advantage in that, after one time of implantation, even if the implanted site is incised without a general anesthesia surgical operation when the drug is repeatedly administered in order to improve the therapeutic effect, the implantation site can be easily recognized and the drug is administered to the site, thereby saving the burden on economy and time and improving the therapeutic effect by repeating the administration.
In addition, according to the drug injection device of the present invention, the movable portion capable of switching the direction and the guide tube inserted therein are rotated in the direction of the target site, which is the focus, and the injection needle is inserted into the guide tube, so that the drug is accurately introduced into the target site, and thus, the accuracy and precision of drug introduction can be improved.
In addition, according to the drug injection device of the present invention, the sealing portion and the movable cover portion are used to block the outside of the skull and the inside of the brain parenchyma, so that the drug backflow and the invasion of external pollutants caused by repeated administration can be prevented, and the side effects caused by infection can be reduced.
In addition, according to the drug infusion device of the present invention, since the drug infusion device is made of a biocompatible material that does not bind to brain tissue after implantation, the safety of implantation is improved, and thus, even if a patient is implanted for a long period of time, the patient does not have immune rejection, and daily activities can be performed.
Drawings
Fig. 1 is an assembled perspective view schematically showing a drug infusion device according to an embodiment of the present invention.
Fig. 2 is a diagram showing a surgical aspect of finding a position of a target site within a patient's cranium using a positioning guide mechanism and setting up the drug infusion device of fig. 1.
Fig. 3 is a sectional view showing a state of injecting a drug after the drug injection device of fig. 2 is provided.
Fig. 4 is a side cross-sectional view schematically illustrating a movable operation after the drug infusion device of fig. 3 is fully assembled.
Fig. 5 (a) to 5 (c) are a plan view, a side view and a side sectional view, respectively, showing a body in the constitution of a drug injection device according to an embodiment of the present invention.
Fig. 6 (a) to 6 (d) are a plan view, a bottom view, a c-c 'side sectional view and a d-d' side sectional view, respectively, showing a body fixing portion in the constitution of the drug injection device according to the embodiment of the present invention.
Fig. 7 (a) to 7 (b) are a side view and a side sectional view, respectively, showing a movable part in the constitution of a drug injection device according to an embodiment of the present invention.
Fig. 8 (a) to 8 (c) are a plan view, a side view and a side sectional view, respectively, showing a movable cover part in the constitution of a drug injection device according to an embodiment of the present invention.
Fig. 9 (a) and 9 (b) are a plan view and a side view, respectively, showing a fastening connection portion in the constitution of the drug infusion device according to the embodiment of the present invention.
Fig. 10 (a) to 10 (c) are a plan view, a side view and a side sectional view, respectively, showing a guide tube in the constitution of a drug injection device according to an embodiment of the present invention.
Fig. 11 (a) and 11 (b) are a perspective view and a side sectional view, respectively, showing a first modification of the sealing portion of the drug infusion device according to the present invention.
Fig. 12 is a side sectional view showing a second modification of the integration of the filter in the sealing portion of the drug injection device according to the present invention.
Fig. 13 is a side sectional view showing deformation of the distal end of the guide tube of the drug infusion device according to the present invention.
Fig. 14 is a side sectional view showing a drug injection device according to a second embodiment of the present invention.
Fig. 15 is a side sectional view showing a drug injection device according to a third embodiment of the present invention.
Fig. 16 is a front view showing a drug infusion device according to a fourth embodiment of the present invention.
Detailed Description
Hereinafter, a positioning guide mechanism according to an embodiment of the present invention will be described in detail with reference to the accompanying drawings. In this case, for convenience and clarity in explanation and understanding of the constitution and operation of the technique, some drawings are exaggerated or simplified, and each constituent element does not exactly correspond to the actual size.
Fig. 1 is an assembled perspective view schematically showing a drug infusion device according to an embodiment of the present invention.
Referring to fig. 1, the medicine injection device 100 may be implanted between the skull 1 and the scalp 3 of the patient P and inject the medicine. The drug infusion device 100 may include a body 110, a body fixation portion 150, a movable portion 130, a sealing portion 160, and a movable cover portion 180, and a fastening connection member 170.
The body 110 and the skull 1 are connected and implanted and fixed, and may be formed with an inner hole. The body 110 and the body fixing portion 150 are coupled adjacent to each other, and the movable portion 130 is accommodated and fixed in the hole in the body 110. The body 110 may include a support portion 115, an insertion portion 113, and a movable receiving hole 110a. The body 110 includes a supporting portion 115 at an upper portion of the skull bone 1 and supporting, and the supporting portion 115 may have an outer diameter smaller than that of the body fixing portion 150 and larger than that of the movable portion 130. The support portion 115 is coupled to the body fixing portion 150 in an adjacent manner, and the movable portion 130 is accommodated and fixed in the hole in the body 110. The support part 115 is positioned at the upper portion of the body 110, and may include at least one first fastening connection hole 110b and at least one fixing protrusion 117, the at least one first fastening connection hole 110b being fixed in such a manner that the fastening connection part 170 is inserted and prevented from moving, and the at least one fixing protrusion 117 being fixed in such a manner as to be combined with the body fixing part 150. The insertion portion 113 is inserted into the skull 1, and may be provided in a connected state. The movable housing hole 110a can house the movable portion 130 inside the body 110.
The body fixing part 150 is formed with an inner hole adjacent to the body 110, and can be combined and fixed and fastened in a facing manner with the body 110. Further, the body fixing part 150 may include a recognition part 157, a fixing hole 150a, a second fastening connection hole 150b, and a support coupling groove 157a. The upper portion of the identification portion 157 protrudes into a curved surface, and can identify the implantation position of the drug infusion device 100. The fixing hole 150a may fix the outside in a form of preventing the movable part 130 from moving at the center. The second fastening connection hole 150b is formed at least one, and may be fixed at an upper circumference in a form in which the fastening connection part 170 is inserted and prevented from moving. The surface of the support coupling groove 157a, which is in contact with the support portion 115, is formed as a concave groove in a shape conforming to the support portion 115, and can be easily coupled to the support portion 115. Further, the support coupling groove 157a may be formed with at least one of a head receiving groove 157b and a protrusion receiving groove 157 c. The head receiving groove 157b serves as a groove for receiving the head 175 of the fastening member 170 protruding from the upper portion to be fastened to the support portion 115, and can reduce friction on the surface where the support portion 115 and the placement portion 155 are in contact with each other when the body 110 and the body fixing portion 150 are coupled. In addition, the head receiving groove 157b can prevent the fastening force with the body fixing portion 150 from being lowered due to interference of the head portion 175 of the fastening connection member 170 fastened with the body 110, and can be easily coupled by being matched with the body fixing portion 150. The protrusion receiving groove 157c is formed in at least one of the support coupling grooves 157a so as to face the fixing protrusion 117 of the support portion 115 and receive it, thereby being coupled.
Accordingly, the body fixing portion 150 and the body 110 have at least three or more coupling forces including the second fastening coupling hole 150b, the supporting coupling groove 157a, and the protrusion receiving groove 157c when coupled, so that they are not separated from each other even when transplanted to the skull bone 1 for a long period of time, and the fixing force can be improved.
The movable portion 130 is located between the body 110 and the body fixing portion 150, and has a medicine injection hole 133 formed in the center thereof, and is capable of switching the direction to the target site 7. The movable portion 130 includes a movable body 131 located in the movable housing hole 110a, and is configured to be curved in shape so as to be capable of changing directions, and a medicine injection hole 133 that is hollow in the center and guides the medicine injection target point 7 may be formed in the movable body 131. The movable portion 130 may be formed in a spherical shape composed of sphericity of less than 0.03 mm. When the movable portion 130 exceeds 0.03mm, the surface contacting the movable accommodation hole 110a of the main body 110 is uneven, and it is difficult to rotate to the desired target point 7 direction. In addition, the surface roughness (R a ) May have a range exceeding 0.1 μm but less than 0.5 μm. If it is less than 0.1 μm, there may occur problems of finely separating sphericity and reducing fixing force, and if it is more than 0.5 μm, the surface becomes more rough, friction is caused when it contacts with the body 110, and thus fixing may be weakened. In other words, there is a limit in that it is difficult to completely rotate when the angle adjustment is performed. In addition, when the drug infusion device 100 is assembled, the reject ratio may be increased.
The medicine injection hole 133 may include a first receiving portion 133a and a second receiving portion 133b. The first receiving portion 133a may receive the sealing portion 160 located in the inner hole of the movable portion 130. The second housing portion 133b is connected to the first housing portion 133a, is positioned at the lower end inside the movable portion 130, and is capable of housing the guide tube 140 and the injection needle 191 inserted at the time of injection of the medicine. The first receiving portion 133a may be formed as a screw from a start point of the inner hole of the movable portion 130 to a point where the sealing portion 160 is received. The sealing part 160 is provided in a form of sealing the medicine injection hole 133 of the movable part 130, and is inserted with an injection needle 191 for injecting medicine. The sealing portion 160 is made of Silicone (Silicone), not limited thereto, and may be made of at least any one of synthetic resin materials. Even if the injection needle 191 is inserted into the sealing part 160, the sealing part 160 is restored to its original form. Thus, the sealing part 160 is inserted into the movable part 130, and cuts off the contamination material from the outside, and can prevent the drug injection device 100 from being infected after being transplanted into the brain.
The movable cover 180 is located above the sealing portion 160, and seals and fixes the movable portion 130, thereby preventing the sealing portion 160 from being separated from the outside. The movable cover 180 may include a needle housing 180a, a position indicator 185, and a movable fastening connection 183. The needle receiving portion 180a may be formed with a hole inclined more downward at the center so as to inject the injection needle 191. The position indication portion 185 includes the needle housing portion 180a inside and may be located outside the movable portion 130. The movable fastening connection portion 183 and the position indication portion 185 are connected, and a screw thread is formed at the outside thereof, and the medicine injection hole 133 can be fastened by the screw thread constituting the male and female.
Referring to fig. 1, the drug infusion device 100 may further include a guide tube 140. The guide tube 140 is connected to the movable portion 130, and is inserted into the brain parenchyma 5 to a position close to the target site 7, and can guide the injection needle 191 for injecting the drug into the target site 7 in the direction of the target site 7. The guide tube 140 coupled to the movable portion 130 can be inserted from the center axis CL toward the target site 7 with reference to the point where the guide tube contacts the skull 1. The guide tube 140 may include a tube connection portion 145 disposed at a lower end of the medicine injection hole 133 and connecting between the movable portion 130 and the guide tube 140. The pipe connection portion 145 may be formed with a hole elongated with the inside of the guide pipe 140.
At least one of the body 110, the body fixing portion 150, the movable portion 130, the movable cover portion 180, and the guide tube 140 of the drug infusion device 100 according to the present invention may be made of Polyetheretherketone (PEEK), but is not limited thereto, and may be variously applied and manufactured if it is a material having body graft adhesiveness.
The fastening connection part 170 may include at least two for fastening the upper portion of the body 110 and the upper portion of the body fixing part 150 to the skull bone 1. The fastening connection member 170 may include a body portion 173 and a head portion 175. The main body 173 may vertically fix at least any one of the body 110 and the body fixing portion 150 in the skull bone 1. The body portion 173 is vertically fixed in the skull 1, is threaded up to the tip in a tapered form, and may be formed with at least one relief groove 173a. The head portion 175 is provided so as to be connected to the main body portion 173, and may include a horizontal groove 175b and a recognition groove 175a, the horizontal groove 175b being located at the center, and the recognition groove 175a being formed so as to be distinguishable from the horizontal groove 175b in a line shape having a horizontal axis and a vertical axis, the line shape being horizontal to the fastening tool during fastening. The fastening member 170 may be made of a titanium material, but is not limited thereto, and may be variously applied and manufactured if it is a material having body graft adhesion and graft stability.
Fig. 2 is a view showing an operation mode in which a target site in the skull of a patient is found using a positioning guide mechanism and the drug injection device of fig. 1 is set, and fig. 3 is a sectional view showing a mode in which the drug is injected after the drug injection device of fig. 2 is set.
Referring to fig. 2 and 3, when a brain disease patient P who needs to have a drug injected into the brain is subjected to an operation, the drug injection device 100 can be guided to be inserted by the positioning guide 10. Here, the brain disease may be, for example, brain tumor, cerebral apoplexy, senile dementia (Alzheimer's disease), parkinson's mental disease, depression, schizophrenia, and other related diseases. The drug infusion device 100 may be cut in a U-shape at the temporal bone, the parietal bone, etc. position in the skull 3 in order to perforate and implant the skull 3 of the patient P. Further, the drug infusion device 100 includes a body 110, a movable portion 130, a guide tube 140, a body fixing portion 150, a sealing portion 160, and a movable cover portion 180. The body 110 is implanted in the skull 3, the upper end of the body 110 is located between the scalp 5 and the skull 3, and the lower end of the body 110 can be inserted into and located within the skull 3. The movable part 130 is inserted into the body 110, has a spherical shape with an open upper part, and can be turned to the target site 7, which is a lesion in the brain parenchyma.
Referring to fig. 2, the positioning guide 10 may guide the guide pipe 140 coupled to the movable part 130 and located at the center axis CL so as to be turned from the center axis CL and located at the target site 7. Here, the positioning guide 10 may include a guide handle 13, a position adjustment portion 15, a position adjustment handle portion 17, and a bolt portion 19. In detail, the guide handle 13 may be provided to the movable portion 130, and the guide tube 140 may be inserted into the guide tube by being coupled to a position adjusting portion provided in a long rod shape. In order to prevent the position adjustment portion 15 from rattling or breaking during insertion, the position adjustment handle portion 17 may be integrally provided at the distal end of the position adjustment portion 15. The guide mechanism 100 is positioned so that the guide tube 140 is positioned in close proximity to the target site 7, and then can be removed from the skull 3.
Fig. 2 shows only the final pattern of the guide tube 140 at the target site 7 by the positioning guide mechanism 100. Although not shown in the drawings, the positioning guide 10 may further include a connection guide (not shown). The connection guide can guide the guide tube 140 to be accurately inserted into the guide tube handle 13. The connection guide portion is formed in at least one pair of tube shapes, and can be separated from each other and additionally provided at the upper end of the guide handle 13. In addition, one end of the connection guide portion is inserted into the guide handle 13, and the other end is placed on the upper portion of the guide handle 13, so that the inserted guide tube 140 can be further inserted. The connection guide portion can be separated and removed if it comes into contact with the inserted pipe connection portion 145. After removal, as shown in fig. 2, the front end of the position adjustment handle portion 17 may be located at the lower end of the movable portion 130 while pushing the pipe connection portion 145.
As shown in fig. 3, an injection needle 191 for administering a drug related to brain disease may be inserted into the guide tube 140. Here, the injection needle 191 may house a trocar, an inspection needle, or the like therein, for example. However, without limitation thereto, a variety of surgical instruments and devices may be inserted, such as navigation probes, stimulation leads, ablation probes or catheters, injection or fluid delivery devices, biopsy needles, extraction tools, and the like, to perform diagnostic and/or therapeutic procedures.
In addition, drugs associated with various brain diseases can be injected using the drug injection device 100. For example, it may include amyloid hypothesis (substance inhibiting β -amyloid protein production), aβ protein aggregation inhibitor, tau aggregation inhibitor cholinesterase inhibitor, NMDA receptor or antagonist, cholinergic precursor, antioxidant substance, dementia-related chemical drugs such as diabetes therapeutic agent, stem cells such as human umbilical cord blood cells, human umbilical cord blood-derived mesenchymal stem cells, neural stem cells, bone marrow stem cells, psychotic therapeutic drugs such as parkinson, depression, and schizophrenia, brain tumor-related therapeutic drugs, and the like.
With reference to fig. 2 and 3, a detailed description will be given of a setting operation method of the drug infusion device 100 according to the present invention.
< surgical method >
A pre-operative preparation step S10 is performed, the position of the target site 7 is found by MRI imaging with a navigation device (not shown), and the position is marked on the skull 1 on coordinates.
The preoperative preparation step S10 may include a step S11 of inputting a position using the navigation probe and transmitting an image and a photograph through the MRI apparatus.
Step S13 may be included to find the position of the target site 7 in the patient P, i.e., the human brain, based on the MRI imaged image or photograph, and then mark a plurality of sections that are standard on the scalp 3, i.e., the subcutaneous layer.
The types of navigation probes can be classified into measurement probes and verification probes. The scalp 3 of the patient P may be marked after the route is confirmed before the puncture with the verification probe. Step S15 may be included of positioning the scalp 3 of the patient P at the marked site, for example, according to "L",the shape of the ' and ' S ' is cut.
Step S17 may be included, after which the incised part may be unfolded and the incised subcutaneous layer 5 may be cinched up and fixed by using a surgical thread in order to secure a space for perforation, so as to prevent the incised part from being unfolded during surgery. At this time, fixation and deployment may be performed using forceps (forceps) or the like. In addition, step S17a may be included, in order to secure the field of view and the visible distance during the operation, foreign substances, blood, and the like are sucked in by using physiological saline and a suction catheter whenever necessary, thereby securing the field of view.
Step S19 may be included to remove bone residues or residues with forceps (pins) after perforation of the cut and exposed skull 1.
Step S20 may be performed to cut the scalp 5 of the patient P, perforate the skull 1, and implant the drug injection device 100 at the perforation position.
In step S30, after the body 110 is first transplanted and fixed to the skull 1 and fastened, the movable portion 130 may be inserted into the movable receiving hole 110a, and at least two fastening members 170 may be provided in the first fastening hole 110 b.
In step S40, the movable part 130 is placed in the middle, and the body fixing part 150 may be provided in a facing manner on the upper part of the body 110. The fixing hole 150a formed in the body fixing portion 150 and the movable receiving hole 110a of the body 110 may be provided in communication with each other while receiving the movable portion 130.
Then, at least two fastening connection members 170 are provided in the second fastening holes 150b formed in the body fixing part 150. At this time, step S50 may be performed by fixing the fastening member 170 only to the extent that the movable portion 130 is movable, and providing the guide handle 13 to the movable portion 130.
Step S60 may be performed by providing a probe housing part (not shown) incorporating the light guide 123 inside the guide handle 13, and inserting a navigation probe (not shown) into the interior thereof, and adjusting while switching the direction so as to find the target site 7.
In step S70, after the accurate target point 7 is set, the navigation probe (not shown) and the probe housing portion (not shown) can be separated from the guide handle 13.
In step S80, the guide tube 140 including the tube connecting portion 145 is prepared. Then, the position adjustment handle portion 17 and the bolt portion 19 are fastened to the position adjustment portion 15, thus preparing a set. At this time, if the position adjustment handle portion 17 reaches the portion in contact with the pipe connecting portion 145, the bolt portion 19 can be fastened and fixed to the fastening connection housing portion 179 of the position adjustment handle portion 17.
In step S90, a pair of detachable connection guides (not shown) may be provided at the upper end of the guide handle 13, and the guide tube 140 including the position adjusting portion 15 may be additionally guided to be inserted into the inner center thereof. If the pipe connection portion 145 is brought into contact with the connection guide portion (not shown), the connection guide portion (not shown) is removed separately, and the front end of the position adjustment handle portion 17 is inserted while pushing the pipe connection portion 145 until it is positioned at the lower end of the movable portion 130.
In step S100, the position adjustment unit 15 is rotated in the direction of the target site 7 in the brain parenchyma 5 while being moved together with the distal end of the guide tube 140, and the position adjustment handle 17 can be adjusted so as to reach the target site 7 earlier than the guide tube 140.
In step S110, if the guide tube 140 is located near the target site 7, the position adjustment unit 15 assembly is separated and removed from the guide handle 13, and finally the guide handle 13 is also separated and removed from the movable unit 130.
In the method of rotating the guide tube 140 in the direction toward the target site 7 in the brain parenchyma 5, the position adjustment handle 17 included in steps S50 to S110 is not limited to being used, and steps S50 to S110 may be omitted, and the movable portion 130 into which the guide tube 140 is inserted may be positioned at the target site 7 only by rotating the movable portion by a maximum angle of 60 °.
In step S120, the sealing part 160 is inserted into the movable part 130 rotated toward the target site 7 in the brain parenchyma 5, and the movable cover part 180 may be fastened and disposed at the upper part thereof by a special screwdriver (not shown). In addition, the fastening connection member 170 loosely positioned at the upper portion of the body 110 is fastened again, so that the medicine injection device 100 can be fixed to the skull 1 of the patient P.
In step S130, after the initial implantation of the drug infusion device 100 is completed, the position indicator 185 of the movable cover 180 can be visually recognized and the position can be found.
In step S140, the injection needle 191 containing the therapeutic agent 195 is sequentially inserted into the target site 7 along the needle housing portion 180a of the movable cover portion 180, the sealing portion 160, the insertion guide hole 145a of the tube connecting portion 145, and the guide tube 140, and then the therapeutic agent 195 can be repeatedly injected for a long period of time.
Specifically, the medicine injection step S140 may include a step S145 of introducing the medicine into the injection needle 191 containing the therapeutic agent 195 after the injection needle 191 passes through the movable cover 180, the needle housing 180a, the sealing part 160, the insertion guide hole 145a, and the guide tube 140 in this order, and reaches the final target position 7. Here, the insertion guide hole 145a and the needle receiving portion 180a may be formed to have a shape having a narrower downward end like a funnel, respectively, so that the medicine may smoothly flow into the guide tube 140. In addition, step S147 may be included in which the injection needle 191 containing the therapeutic agent 195 is repeatedly administered for a long period of time after reaching the final target site T. At this time, step S149 may be included in which at least one or more medicine introduction holes 140a are formed in order to prevent medicine from accumulating at the tip of the guide tube 140, so that the medicine is not accumulated at the tip but uniformly dispersed at the target site 7, thereby introducing the medicine.
Fig. 4 is a side cross-sectional view schematically illustrating a movable operation after the drug infusion device of fig. 3 is fully assembled.
Referring to fig. 4, the drug infusion device 100 according to the present invention may include a body 110, a movable part 130, a body fixing part 150, a guide tube 140, a sealing part 160, and a movable cover part 180 and be completely assembled. The body 110 has a lower end into which the insertion portion 113 of the skull 1 is inserted, and an upper end may include a support portion 115 that horizontally supports the upper portion of the skull 1. The placement portion 155 of the body fixing portion 150 may be provided to the support portion 115 in a connected manner. At this time, in order to further improve the coupling fixing force between the body 10 and the body fixing part 150, a fastening connection member 170 may be further provided therebetween. In detail, a second fastening connection hole 150b may be formed at one end of the support portion 115, and a fastening connection member 170 may be provided at the second fastening connection hole 150 b. Further, a head receiving groove 157b is formed at the other end of the support portion 115 so as to face the first fastening hole 110b of the body 110, and a head portion 175 of the fastening member 170 fastened to the first fastening hole 110b can be attached. Accordingly, the first fastening connection hole 110b and the second fastening connection hole 150b of the medicine injection device 100 are formed at least three points different from each other, respectively. In other words, at least six points may be provided with the fastening connection part 170 when the body 110 and the body fixing part 150 are fastened and connected. Accordingly, the drug infusion device 100 can maintain an initial implant fixation force after implantation such that the body 110 and the body fixation portion 150 are not easily separated.
The movable housing hole 110a formed in the center of the body 110 may be provided with a movable body 131, which is formed in a curved surface so as to be capable of changing directions. A medicine injection hole 133, which is hollow at the center and guides medicine injection into the target site 7, may be formed in the movable body 131. A guide tube 140 is provided at the lower end of the medicine injection hole 133 so as to be rotatable toward the target site 7. That is, the guide tube 140 coupled to the movable portion 130 is rotatable from the center axis CL in the direction of the target site 7 on the left and right sides by a maximum angle of 60 ° or less with respect to the surface in contact with the skull 1. When the maximum angle exceeds 60 °, an excessive load is generated on one side surface of the placement portion 155 coupled to the support portion 115, and thus the coupling is unbalanced, so that the placement portion 155 may be separated. When the guide tube 140 provided in the movable portion 130 is positioned in the direction of the destination point 7, the tube connecting portion 145 may be attached to the drug injection hole 133, and the sealing portion 160 may be provided above the tube connecting portion 145. Here, the sealing part 160 may have a certain height L 6 Outer diameter dimension D 10 So as to be inserted inside the movable portion 130. The condition range of the sealing portion 160 will be described later with reference to fig. 8. A movable fastening connection member 170 of a movable cover 180 may be provided on the upper portion of the sealing portion 160. The movable cover 180 may be formed with a hollow needle housing 180a in the center. Further, the position indication portion 185 of the movable cover 180 is formed in a hexagonal shape, and can indicate the position of implantation. Therefore, when the drug infusion device 100 is implanted in the skull 1 and then the covering scalp 3 is sewn, the implantation position is found by the position indicator 185, and the injection needle 191 can be inserted into the guide hole 145a of the tube connecting portion 145 in accordance with the needle housing portion 180a, the sealing portion 160, and the tube connecting portion 145 And sequential insertion of guide tubes 140.
Fig. 5 (a) to 5 (c) are a plan view, a side view and a side sectional view, respectively, showing a body in the constitution of a drug injection device according to an embodiment of the present invention.
Referring to fig. 5 (a) to 5 (c), the body 110 may be formed with a movable receiving hole 110a in which the movable portion 130 is received. The body 110 is positioned above the skull 1, and may include a support portion 115 fixedly supported by the skull 1 of the patient P and an insertion portion 113 inserted into the skull 1.
The body 110 may satisfy at least one of the following expressions 1 and 2.
[ mathematics 1]
1＜D 1 /D 2 ≤3
[ math figure 2]
2≤L 1 ≤7[mm]
Here, D 1 Is the outer diameter dimension D of the insertion portion 113 2 Is the inner diameter dimension L of the movable accommodation hole 110a 1 Is the insertion depth of the insertion portion 113.
When the lower limit value of expression 1 is deviated, the thickness of the main body 110 becomes small, and it is difficult to fix the movable part 130, and when the upper limit value of expression 1 is deviated, the movable part 130 may not be attached and may be exposed to the outside, and thus the risk of infection or the like may increase. Thus, when the condition range of the expression 1 is satisfied, the body 110 may have a proper thickness and be positioned between the skull 1 and the scalp 3 such that the movable portion 130 is mounted in the movable receiving hole 110a and combined.
In addition, when the lower limit value of expression 2 is deviated, the insertion portion 113 has a height lower than the thickness of the skull 1, so that a space for accommodating the movable portion 130 cannot be generated, and when the upper limit value of expression 2 is deviated, the body 110 exceeds the thickness of the skull 1, so that the thickness of the insertion portion 13 for pressing the brain parenchyma 5 is increased, and thus, side effects such as headache and dizziness may be caused to the patient P after the operation. Therefore, in the case where the condition range of the expression 2 is satisfied, the insertion portion 113 may have an appropriate height to be inserted into the cranium 1 without pressing the brain parenchyma 5.
The support portion 115 may include a first fastening connection hole 110b and a fixing protrusion 117. The first fastening connection hole 110b is provided with at least one at an upper portion of the body 110, and can be fixed in a form in which the fastening connection part 170 is inserted and prevented from moving. The fixing protrusion 117 is formed to be at least one and may be fixed in combination with the body fixing part 150.
The fixing protrusion 117 and the first fastening connection hole 110b formed with at least one may satisfy the following equation 3.
[ math 3]
12≤D 3 /L 2 ≤60
Here, D 3 Is the outer diameter dimension L of the support portion 115 2 Is the height of the support 115.
When the lower limit value of expression 3 is deviated, the height is large with respect to the outer diameter of the supporting portion 115, and therefore, it is difficult to stably attach to the skull bone 1, and when the upper limit value of expression 3 is deviated, the outer diameter of the supporting portion 115 becomes large, the distance between the first fastening holes 110b becomes long, and the fixing force may become weak with the lapse of time. Thus, when the condition range of the formula 3 is satisfied, the support portion 115 is easily placed in the insertion portion 113 inserted into the skull bone 1, and the fixing protrusion 117 and the first fastening hole 110b can be formed to have the optimal diameter and height, so that the fixing force and stability can be ensured.
The fixing projection 117 may satisfy the following equation 4.
[ mathematics 4]
0.3≤D 4 /L 3 ≤5
Here, D 4 Is the outer diameter dimension L of the fixing projection 117 3 Is the height of the fixing projection 117.
When the lower limit value of expression 4 is deviated, the height of the fixing protrusion 117 becomes high, and the fixing protrusion 117 is easily broken when coupled to the body fixing portion 150, and even if the fixing connection is performed, a problem may occur in that a part of the body fixing portion 150 is lifted upward and the movable portion 130 cannot be fixed, and when the upper limit value of expression 4 is deviated, the height of the fixing protrusion 117 becomes low, and the fixing function of the fixing protrusion 117 may be lost. Therefore, when the condition range of the expression 4 is satisfied, the support portion 115 is not rotated or separated after being fastened to the body fixing portion 150, and the fixing force can be maintained even when time elapses.
Fig. 6 (a) to 6 (d) are a plan view, a bottom view, a c-c 'side sectional view and a d-d' side sectional view, respectively, showing a body fixing portion in the constitution of the drug injection device according to the embodiment of the present invention.
Referring to fig. 6 (a) to 6 (d), the body fixing part 150 may be combined and fixed and fastened in a manner facing the body 110. The body fixing part 150 may be formed at the center with a fixing hole 150a to fix the outside in a form to prevent the movable part 130 from moving. Further, the body fixing part 150 may be formed at an upper circumference with at least one second fastening connection hole 150b for fixing in a form in which the fastening connection member 170 is inserted and prevented from moving.
Fig. 6 (c) is a side sectional view taken along c-c' when the body fixing portion 150 is cut in plan view (a). A fixing hole 150a is formed at the center of the upper end of the body fixing part 150, and a second fastening connection hole 150b is formed at the placement part 155 provided to face the body 110, so that a coupling fastening connection member 170 can be provided.
Fig. 6 (d) is a side sectional view taken along d-d' when the bottom surface view (b) of the body fixing portion 150 is cut. The body fixing part 150 is formed with a fixing hole 150a at the center, and may include a recognition part 157 capable of recognizing a graft position when seen from the outside. When the identification portion 157 is compared with the placement portion 155, it has a bulging shape, and a head receiving groove 157b facing the first fastening hole 110b of the body 110 may be formed in the bottom surface thereof. The head receiving groove 157b may be placed by the head portion 175 of the fastening connection member 170 provided in the first fastening connection hole 110 b.
The fixing hole 150a and the body fixing portion 150 satisfy the following equation 5 and/or the height of the body fixing portion 150 is at least any one of 1mm to 9 mm.
[ math 5]
1＜D 6 /D 5 ≤7.5
Here, D 5 Is the outer diameter dimension of the fixing hole 150a, D 6 Is the outer diameter dimension of the body securing portion 150.
When the lower limit value of equation 5 is deviated, the fixing hole 150a in the center of the body fixing portion 150 is enlarged, and thus the portion exposed to the outside is increased, and an infection problem occurs, and when the upper limit value of equation 5 is deviated, the fixing hole 150a in the center of the body fixing portion 150 is too small, and therefore at least one of the sealing portion 160 and the movable portion 130 may be difficult to be inserted into the fixing hole 150 a. Accordingly, when the condition range of equation 5 is satisfied, the sealing portion 160 and the movable portion 130 are inserted into the fixing hole 150a so that the sealing portion can be easily coupled to the body 110 and the fixing force can be maintained, thereby blocking the external contaminants and preventing infection.
In addition, when the height of the body fixing part 150 is out of the range of 1mm to 9mm, the height of the scalp 3 of the patient P is increased, and a bulge is formed in appearance after implantation, which may cause inconvenience to the daily life of the patient P. Therefore, the height of the body fixing portion 150 satisfies the range of 1mm to 9mm, and there is no particular difference in appearance after implantation, so that inconvenience felt by the patient P is reduced, damage caused by external impact is reduced, and smooth daily life of the patient P can be maintained.
Referring to fig. 6 (a) and 6 (b), the body fixing part 150 may include a recognition part 157, a fixing hole 150a, a second fastening connection hole 150b, and a support coupling groove 157a. The upper portion of the identification portion 157 protrudes into a curved surface, and can identify the implantation position of the drug infusion device 100. The fixing hole 150a may fix the outside in a form of preventing the movable part 130 from moving at the center. The second fastening connection hole 150b may be formed at least one, and fixed at an upper circumference in such a manner that the fastening connection part 170 is inserted and prevented from moving. The lower portion of the supporting coupling groove 157a is concavely formed in a curved surface to conform to the shape of the supporting portion 115 of the body 110, and can be easily coupled. Further, the inside of the support coupling groove 157a includes at least one protrusion receiving groove 157c coupled in a form facing the fixing protrusion 117, and the support coupling groove 157a may satisfy the following equation 6.
[ math figure 6]
5＜R 1 ≤15[mm]
Here, R is 1 The radius of the support coupling groove 157a is shown.
When the lower limit value of equation 6 is deviated, the support portion 115 is difficult to be accommodated when the body 110 is coupled, so that the fixing force may be weakened, and when the upper limit value of equation 6 is deviated, there is a space left even when the body 110 is accommodated, so that the coupling fixing force with the body 110 is weakened. Accordingly, when the condition range of expression 6 is satisfied, the support coupling groove 157a may have a certain area generated when the circle is three-equal, and thus, the shape of the support portion 115 is identical, and even if the coupling is performed for a long period of time, the separation is not performed, and the fixing force is maintained.
Fig. 7 (a) to 7 (b) are a side view and a side sectional view, respectively, showing a movable part in the constitution of a drug injection device according to an embodiment of the present invention.
Referring to fig. 7 (a) and 7 (b), the movable part 130 is located between the body 110 and the body fixing part 150, and a medicine injection hole 133 is formed at the center, so that the position can be adjusted to the target site 7. The movable part 130 may include a movable part 130 and a medicine injection hole 133. The movable portion 130 is positioned between the movable housing groove 110a and the fixed hole 150a, and the movable portion 130 is formed in a curved surface so as to be adjustable in position. The medicine injection hole 133 may be formed with an internal hole so as to inject medicine into the cranium 1.
The movable part 130 may satisfy the following equation 7.
[ math 7]
0.4≤D 8 /L 5 ≤20
Here, D 8 Is the outer diameter dimension L of the movable part 130 5 Is the height of the movable portion 130.
Since the height of the movable portion 130 increases when the lower limit value of equation 7 is deviated, the movable portion 130 is restricted and hardly rotated when the inner space enough to be inserted into the sealing portion 160 is prepared, and the outer diameter of the movable portion 130 increases when the upper limit value of equation 7 is deviated, and the main body fixing portion 150 may be hardly fastened to the upper portion. In addition, the patient P may be inconvenienced and have side effects after the operation of pressing the brain parenchyma 5. Therefore, when the condition range of expression 7 is satisfied, the movable portion 130 has a ball shape, is positioned between the body 110 and the body fixing portion 150, and can rotate toward the target site 7.
The medicine injection hole 133 may include: a first housing portion 133a for housing a seal portion 160 located in an inner hole of the movable portion 130; and a second housing portion 133b connected to the first housing portion 133a, located at a lower end of the inside of the movable portion 130, for housing an injection needle inserted at the time of injection of the medicine. The first receiving portion 133a may be formed as a screw thread from the start point of the internal hole of the movable portion 130 to the point of receiving the sealing portion 160.
The first housing portion 133a and the second housing portion 133b may satisfy at least one of the following conditional expressions 8 and 9, respectively.
[ math figure 8]
55≤V 1 ≤80[mm 3 ]
[ math figure 9]
0.5≤D 9 ≤2[mm]
Here, V 1 Is the volume of the internal space of the first accommodation portion 133a, D 9 Is the inner diameter of the second receiving portion 133 b.
When the inner space volume of the first housing portion 133a is larger than the inner diameter size of the second housing portion 133b and the lower limit value of equation 8 is deviated, it may be difficult to find and insert the second housing portion 133b when the guide tube 140 is inserted, and when the inner space volume of the second housing portion 133b is larger than the inner space volume of the first housing portion 133a and the upper limit value of equation 8 is deviated, it may be difficult to determine the position when the guide tube 140 is inserted and the fixing force may be reduced with the lapse of time after the implantation. Accordingly, when the condition range of expression 8 is satisfied, the sealing portion 160 can be accommodated in the first accommodation portion 133a, and the external contaminant can be blocked, so that the sealing portion can be protected from penetration into the brain parenchyma 5. Further, since a space in which the medicine can be stored in the first storage portion 133a can be ensured, it is possible to accumulate a certain amount of medicine, such as a therapeutic agent for dementia and a therapeutic agent for pain associated with brain disease, which needs to be repeatedly administered, and to administer the medicine to the target site 7 while passing through the guide tube 140. Therefore, the first and second housing portions 133a and 133b of the movable portion 130 satisfying the condition range of expression 8 can improve the repeated medication function of the medication injection device 100.
Further, when the lower limit value of expression 9 is deviated, it may be difficult to insert the guide pipe 140 into the second housing portion 133b, and when the upper limit value of expression 9 is deviated, the inner diameter of the second housing portion 133b may be larger than the outer diameter of the guide pipe 140, and thus an excessive space, that is, a gap may be generated. Because of this gap, the drug may be administered to other brain parenchyma 5 parts of the non-target site 7 when injected, resulting in side effects. Accordingly, when the condition range of expression 9 is satisfied, the inner diameter of the second housing portion 133b is matched and coupled to the outer diameter of the guide tube 140, so that the medicine can be accurately and precisely administered to the target site 7 at the time of injection.
The side surface of the first receiving portion 133a may be formed as a screw from the start point of the internal hole of the movable portion 130 to the point where the sealing portion 160 is received.
Here, the height at which the screw thread is formed may satisfy the following equation 10.
[ math figure 10]
0.2≤L 5a /L 5 ≤0.7
Here, L 5 L represents the overall height of the first and second housing portions 133a and 133b 5a Representing the height formed by the threads.
When the lower limit value of expression 10 is deviated, the height formed by the screw thread may be difficult to be fastened to movable cover 180, and when the upper limit value of expression 10 is deviated, most of the entire height of first housing portion 133a and second housing portion 133b is the same as the height formed by the screw thread, so that sealing portion 160 is difficult to be housed in second housing portion 133b, and even if housed, sealing portion 160 is damaged by the screw thread portion on the side surface. Therefore, when the condition range of the expression 10 is satisfied, the entire height of the first and second housing portions 133a and 133b can house the sealing portion 160 and the guide tube 140, and the height formed by the screw thread can be fastened to the movable cover portion 180, so that the contaminant can be blocked from the outside.
Fig. 8 (a) to 8 (c) are a plan view, a side view and a side sectional view, respectively, showing a movable cover part in the constitution of a drug injection device according to an embodiment of the present invention.
Referring to fig. 8 (a) to 8 (c), the movable cover part 180 may include a needle housing part 180a, a position indication part 185, and a movable fastening connection part 183. The needle housing portion 180a may have a funnel shape which is narrower toward the inside as a hole into which the injection needle 191 is injected in the center of the movable cover portion 180, so that the injection needle 191 can be inserted toward the center even if inserted in any direction. The position indication part 185 is formed in a hexagonal shape at an upper portion of the movable part 130, and corner parts of the hexagonal shape may be molded. However, the present invention is not limited thereto, and various shapes capable of indicating positions may be applied. Therefore, the position indication portion 185 may have an identification function so that the drug injection position can be found by the needle housing portion 180a partially contacting the hands of the operator when the drug is repeatedly put into the drug injection device 100. The movable fastening portion 183 is connected to the position indicator 185, and is externally threaded, so that it can be fastened to the medicine injection hole 133 by the male and female screw.
The seal 160 and the movable cover 180 may satisfy at least one of the following expressions 11 and 12.
[ mathematics 11]
1＜D 11 /D 10 ≤7.2
[ math figure 12]
0.4≤L 7 /L 6 ≤20
Here, D 10 Is the outer diameter dimension of the sealing portion 160, D 11 Is the outer diameter dimension L of the movable cover 180 6 Is the height of the sealing part 160, L 7 Is the height of the movable cover 180.
When the lower limit value of expression 11 is deviated, the outer diameter of the sealing portion 160 becomes larger, and the movable cover portion 180 blocking the upper portion thereof can be pushed away, and foreign matter from the outside may penetrate into the gap pushed away, possibly inducing side effects. When the upper limit value of expression 11 is deviated, the sealing portion 160 may be relatively small, and thus may not be fixedly located in the movable portion 130, making it difficult for the injection needle 191 inserted through the movable cover portion 180 to pass through the sealing portion 160. Thus, when the condition range of expression 11 is satisfied, the movable cover 180 can always block the seal 160, and foreign matter can be prevented from penetrating from the outside.
Further, since the height of the sealing portion 160 is relatively high when the lower limit value of equation 12 is deviated, the movable cover portion 180 may be difficult to be fastened to the inside of the movable portion 130, and since the height of the movable cover portion 180 is relatively large when the upper limit value of equation 12 is deviated, the fixing hole 150a of the body fixing portion 150 may be deviated after the movable cover portion is fastened to the movable portion 130, and may protrude significantly higher than the scalp 3. This state may cause inconvenience in daily life and, more serious, may cause side effects such as pain induction after the drug infusion device 100 is implanted. Accordingly, when the condition range of equation 12 is satisfied, the sealing portion 160 is suitably accommodated in the movable portion 130, and the upper movable cover portion 180 is blocked, so that foreign matter and contamination outside can be blocked, and thus, the transplanting suitability and stability can be provided. Further, the sealing part 160 and the movable cover part 180 having appropriate heights may not be located between the skull 1 and the scalp 3 so that the patient P may smoothly perform daily life after implantation.
The needle housing portion 180a can satisfy the following expression 13.
[ math 13]
A 1 ≥A 2
Here, A 1 An angle a representing an upper end of the needle housing portion 180a in an angle formed to be left and right with respect to the central axis 2 The angle of the middle portion of the needle housing portion 180a is shown.
When the condition falls outside the condition range of expression 13, the angle of the intermediate portion of the needle 191 when passing through the upper end of the needle housing 180a increases sharply, and the path direction of the needle 191 changes, and the needle 191 breaks or is difficult to insert. When the condition range of expression 13 is satisfied, the injection needle 191 can be inserted into the desired target point 7 through the lower end portion of the needle housing portion 180a even if the injection needle 191 is inserted into an arbitrary direction when the outside is in contact with the upper end of the needle housing portion 180 a.
The position indicator 185 may satisfy the following expression 14.
[ math 14]
0.4≤L 7a /L 7 ＜1
Here, L 7 Indicating the overall height of the movable cover 180, L 7a The height of the position indicator 185 is shown.
In the case of deviating from the lower limit value of equation 14, the movable fastening connection portion 183 occupies a large part in the movable cover portion 180, and thus can be easily fastened to the movable portion 130, but in the process of setting and separating and removing, it may be difficult to separate the movable cover portion 180 from the movable portion 130, and in the case of deviating from the upper limit value of equation 14, the movable fastening connection portion 183 occupies almost no proportion in the movable cover portion 180, and thus, it may be difficult to be fastened to the movable portion 130. Therefore, when the condition range of expression 14 is satisfied, the movable cover 180 is fastened to the movable part 130, and inflow of the contaminant from the outside can be blocked, and the coupling and the decoupling are easy.
Fig. 9 (a) and 9 (b) are a plan view and a side view, respectively, showing fastening connection members in the constitution of the drug infusion device according to the embodiment of the present invention.
Referring to fig. 9 (a) and 9 (b), the fastening connection member 170 may include at least two fastening connection members for fastening the upper portion of the body 110 and the upper portion of the body fixing portion 150 to the skull bone 1. The fastening connection part 170 may include a body portion 173 vertically fixed in the cranium and a head portion 175 placed in a form of being connected with the body portion 173.
The body 173 and the head 175 may satisfy at least one of the following expressions 15 and 16.
[ math 15]
1＜D 12 /D 11 ≤50
[ math 16]
1＜L 9 /L 8 ≤100
Here, D 11 Represents the outer diameter dimension of the main body 173, D 12 Indicating the outer diameter dimension, L, of the head 175 9 Indicating the length of the main body 173, L 8 Representing the length of the head 175.
When the lower limit value of the expression 15 is deviated, the diameter of the main body 173 is larger than the diameter of the head 175, and therefore, the head 175 may be relatively enlarged to be disturbed by the main body fixing portion 150, the fastening connection is difficult, and the force to the main body 173 is relatively weakened, so that the fixing force is lowered, and thus, the stable fastening connection cannot be realized. Therefore, when the condition range of the expression 15 is satisfied, the fastening connection member 170 can fix the body 110 and the body fixing portion 150, and the implantation stability and the fixing force of the drug infusion device 100 can be improved.
In addition, when the lower limit value of equation 16 is deviated, the length of the head 175 is relatively long, and thus it may be difficult to fixedly support the transplanted body 173, and when the upper limit value of equation 16 is deviated, the body 173 is relatively long, and thus the brain parenchyma 5 is pressed while being deviated from the skull 1, and side effects may be caused after the transplantation. Accordingly, when the condition range of expression 16 is satisfied, the fastening and connecting member 170 has an appropriate ratio between the head portion 175 and the body portion 173, and can stand on the skull 1 to fix the drug injection device 100.
The head portion 175 may include a horizontal groove 175b and a recognition groove 175a, the horizontal groove 175b being centrally located, and being fastened to the fastening tool horizontally, the recognition groove 175a being formed in a line shape divided into a horizontal axis and a vertical axis with respect to the horizontal groove 175b so as to be able to recognize.
The horizontal groove 175b and the identification groove 175a can satisfy the following equation 17.
[ math 17]
0.06≤D 13 /L 8a ≤12
Here, L 8a Represents the depth of the identification groove 175a, D 13 The outside diameter dimension of horizontal groove 175b is shown.
When the lower limit value of equation 17 is deviated, the length of the identification groove 175a is relatively long, and thus the function of the horizontal groove 175b may be lost, and when the upper limit value of equation 17 is deviated, the outer diameter size of the horizontal groove 175b is relatively large, and thus the identification function of the identification groove 175a may be reduced. Thus, when the condition range of the equation 17 is satisfied, the head 175 may have both the recognition function of the recognition groove 175a and the function of the horizontal groove 175b to fasten the fastening member 170 in a horizontal form.
The body 173 is fixed to the inside of the skull in a standing manner, and is threaded in a tapered shape until the distal end, and at least one relief groove 173a satisfying the following equation 18 may be formed.
[ math figure 18]
1＜L 9 /L 9a ≤50
Here, L 9 Indicating the length of the main body 173, L 9a The length of the portion where the relief groove 173a is formed is shown.
Since the pressure reducing groove 173a is designed to be relatively longer than the length of the main body 173 when the lower limit value of the expression 18 is deviated, the function of the fastening member 170 may be lost, the fixing force may be weakened, and when the upper limit value of the expression 18 is deviated, the pressure to the bone tissue may be increased as the fastening member 170 having almost no pressure reducing groove 173a. In this way, in the case of long-term transplantation, bone tissue is damaged, inflammation may be induced, and in severe cases, side effects of the transplantation operation may be brought about. Thus, when the condition range of the equation 18 is satisfied, the fastening connection member 170 formed with the pressure reducing groove 173a is implanted in the bone, the pressure causing the damage to the bone tissue is relatively weakened, and thus the damage to the bone can be minimized.
Fig. 10 (a) to 10 (c) are a plan view, a side view and a side sectional view, respectively, showing a guide tube in the constitution of a drug injection device according to an embodiment of the present invention.
Referring to fig. 10 (a) to 10 (c), the guide tube 140 may guide an injection needle injecting a medicine into the target site 7 in a target direction. Also, the surface of the guide tube 140 may be smooth to minimize damage through the brain parenchyma 5.
Further, the length of the guide tube 140 may include a range of 10mm to 300mm, and the following equation 19 may be satisfied.
[ math 19]
1＜D 14b /D 14a ≤3.5
Here, D 14a Represents the inner diameter dimension, D, of the guide tube 140 14b Indicating the outer diameter dimension of the guide tube 140.
When the lower limit value of expression 19 is deviated, the needle 191 may be broken or damaged in the guide tube 140 when the needle 191 passes through because the guide tube 140 is thin. In addition, when the guide tube 140 is inserted into the brain parenchyma 5, the strength is too weak, and the guide tube 140 may adhere to the brain parenchyma 5, thereby causing side effects, losing the function of accommodating and guiding the injection needle 191, and when the upper limit value of equation 19 is deviated, the thickness of the guide tube 140 may become thick, and it may be difficult to insert the injection needle 191. Further, since the insertion strength is increased due to the thickness of the guide tube 140, the insertion into the brain parenchyma 5 is damaged. Accordingly, when the condition range of expression 19 is satisfied, the guide tube 140 can be inserted so as to minimize the damage to the brain parenchyma 5, and then the injection needle 191 can be guided to the target site 7 when housed in the guide tube 140.
In addition, the guide tube 140 may further include a tube connection portion 145. The tube connecting portion 145 is disposed at the lower end of the medicine injection hole 133, and connects the movable portion 130 and the guide tube 140, and an insertion guide hole 145a extending from the inside of the guide tube 140 may be formed. The insertion guide hole 145a may have a funnel shape that narrows as it goes down, but is not limited thereto, and may have various shapes that can be guided in the center direction. Thus, the insertion guide hole 145a and the needle housing portion 180a together perform a double guide in the center direction, so that the injection needle 191 can be accurately inserted into the target site 7 even if it is inclined in a direction other than the center when passing through the needle housing portion 180 a.
The pipe connection portion 145 may satisfy at least one of the following expressions 20 and 21.
[ math figure 20]
1＜D 15 /D 16 ≤20
[ math figure 21]
0.5≤L 10 ≤1.5[mm]
Here, D 15 Is the outer diameter dimension D of the pipe connection 145 16 Is the inner diameter dimension, L, of the pipe connection 145 10 Is the height of the tube connection 145.
When the lower limit value of expression 20 is deviated, the inner diameter of the tube connecting portion 145 is relatively increased, and thus the thickness of the tube connecting portion 145 is reduced, and thus the tube connecting portion 145 may be broken or broken when the injection needle 191 is inserted, and when the upper limit value of expression 20 is deviated, the thickness of the tube connecting portion 145 is increased, and thus the inner space is reduced, and thus the insertion and separation of the injection needle 191 may be difficult. Accordingly, when the condition range of the equation 20 is satisfied, the pipe connecting portion 145 is supported and fixed to the lower end of the movable portion 130, so that the pipe connecting portion is not easily separated and separated, and can be stably coupled. The tube connecting portion 145 can be guided in the direction of the target site 7 as the injection needle 191 passes inside.
Further, when the lower limit value of expression 21 is deviated, the height of the pipe connection portion 145 is relatively low, and the fixing force of the support may be weakened, so that the separation from the brain parenchyma 5 may be caused, thereby causing side effects, and when the upper limit value of expression 21 is deviated, the height of the pipe connection portion 145 is relatively high, and there may be a limitation in accommodating the inside of the movable portion 130 together with the sealing portion 160. Accordingly, when the condition range of the expression 21 is satisfied, the pipe connection portion 145 is provided inside the movable portion 133 and can be supported with a fixed force, and the sealing portion 160 is provided at the upper portion thereof, so that external contaminants can be blocked.
The guide tube 140 may be formed with at least one medicine input hole 140a so that medicine flows instead of accumulating on one side or both sides. In addition, the inner and outer diameters of the distal end of the guide tube 140 are formed in a curve, and may have a shape that minimizes tissue damage when inserted into the cranium 1.
At least one of the body 110, the body fixing portion 150, the movable portion 130, the movable cover portion 180, and the guide tube 140 of the drug infusion device 100 may be composed of Polyetheretherketone (PEEK).
The fastening connection part 170 may be formed of a titanium material. However, the drug infusion device 100 and the fastening member 170 are not limited to this, and may be variously applied if they are made of a material that is strong and resistant to external contamination.
Fig. 11 is a perspective view and a side sectional view showing a first modification of the sealing portion of the drug infusion device according to the present invention.
Referring to fig. 11, a central guide groove 160a may be further formed at the center of the sealing part 160. Even if the needle 191 is inserted in the other direction, the central guide groove 160a can guide the needle 191 toward the midpoint. At least three points may be cut in the central guide groove 160a with respect to the central point. In detail, the cutting line may have a "Y" or "X" shape, but is not limited thereto, and may be cut into various shapes with reference to the center point.
Thereby, the center guide groove 160a has the following effects: damage to other locations of the sealing portion 160 can be prevented and the injection needle 191 is continuously guided toward the guide tube 140.
Fig. 12 is a side sectional view showing a second modification of the integration of the filter in the sealing portion of the drug injection device according to the present invention.
Referring to fig. 12, the sealing part 160 may further include a sealing filter membrane 165 to prevent foreign substances from being thrown into the inside. The sealing filter membrane 165 may be an integrated type that integrates the filter and the sealing portion 160 and is easily replaced and installed at one time. The sealing filter 165 may have a hinge portion 165a formed to surround the upper outer side and be bent. When the sealing filter membrane 165 is replaced, a part of the hinge portion 165a can be grasped and easily removed. Thereby, the filtering membrane 165 is sealed at the time of replacement of the sealing part 160 as a consumable, and can be prevented from being detached, and the sealing part 160 can be prevented from being secondarily polluted with the lapse of time, so that the side effects of infection can be reduced.
The sealing portion 160 may include at least one of the first mixture and the second mixture.
The first mixture may be mixed with 55 to 60% by weight of siloxane, polysiloxane, dimethyl and vinyl series, 25 to 30% by weight of silane amine, 1.1.1-trimethylamine trimethylsilyl and silica hydrolysis products, 5 to 7% by weight of siloxane silicon, dimethyl and methyl vinyl.
The second mixture may be mixed with 55 to 60 wt% of siloxane, polysiloxane, dimethyl and vinyl series, 25 to 30 wt% of silane amine, 1.1.1-trimethylamine trimethylsilyl and silica hydrolysis products, 5 to 7 wt% of siloxane silicon, dimethyl and methyl vinyl, 1 to 5 wt% of siloxane silicon, dimethyl and methyl hydrogen.
Thus, the first and second mixtures of the sealing portion 160 can satisfy the following equation 22.
[ math figure 22]
1≤M 2 /M 1 ≤2
Here, M 1 Represents a first mixture, M 2 Representing a second mixture.
When the lower limit value of expression 22 is deviated, the density of the sealing portion 160 may be weakened, and thus the separation may occur over time, and the mixture ratio may become hard or burnt. And many bubbles are generated on the surface of the sealing part 160, and the silicone particles may stick together and penetrate into the brain parenchyma 5 when the injection needle 191 is injected, so that side effects may be caused after implantation. When the upper limit value of expression 22 is deviated, the density of the seal 160 increases, and it is difficult to insert the needle 191 or the needle 191 may be broken. Thus, when the condition range of expression 22 is satisfied, the sealing portion 160 has the most suitable magnification, so that the needle 191 can be easily inserted into the surface thereof, the bonding between the polysiloxane particles is strong, and bubbles hardly occur on the surface of the sealing portion 160.
Fig. 13 is a side sectional view showing deformation of the distal end of the guide tube of the drug infusion device according to the present invention.
Referring to fig. 13, the guide tube 140 may be formed with at least one medicine input hole 140a so that medicine, i.e., the therapeutic agent 195, flows instead of accumulating on one side or both sides. The medicine insertion hole 140a is circular, and may be formed in various shapes. In addition, the inner and outer diameters of the distal end of the guide tube 140 are formed in a curve, so that tissue damage can be minimized when passing through the brain parenchyma 5 together with the injection needle 191.
Fig. 14 is a side sectional view showing a drug injection device according to a second embodiment of the present invention.
Referring to fig. 14, the drug infusion device 200 according to the second embodiment of the present invention may include a body 210, a body fixing part 250, and a sealing part 260. The body 210 is formed with a sealed receiving hole 210a having a hollow center inside, and may be formed with a needle insertion hole 310b connected to the sealed receiving hole 210a for insertion of the injection needle 191. Also, the upper portion of the body 210 includes a support portion 215, and at least two fastening connection holes 210b may be formed in the support portion 215. The seal housing hole 210a has a quadrangular space in which the seal portion 260 can be housed, and the injection needle 191 can pass through the space. The body fixing part 250 is formed at the inner center with a fixing hole 250a, and may be formed at a side thereof with a body sealing part 253 formed by a screw thread so as to be fastened to the inside of the body 210. In contrast to the drug infusion device 100 of fig. 1, the injection needle 191 can be inserted in only one direction by the drug infusion device 200. The injection needle 191 may be inserted into the seal receiving hole 210a after passing through the fixing hole 250a and the sealing part 260. Thus, the drug infusion device 200 according to the second embodiment of the present invention is simple in structure, requires less time for setting and separating removal, and facilitates replacement of the sealing portion 260.
Fig. 15 is a side sectional view showing a drug injection device according to a third embodiment of the present invention.
Referring to fig. 15, a drug infusion device 300 according to a third embodiment of the present invention may include a body 310, a body fixing part 350, and a sealing part 360. The body 310 is formed with a sealed receiving hole 310a having a hollow center inside, and may be formed with a needle insertion hole 310b connected to the sealed receiving hole 310a for insertion of the injection needle 191. Also, the upper portion of the body 310 includes a supporting portion 315, and at least two fastening connection holes 310b may be formed in the supporting portion 315. In the space having a quadrangular shape in the seal housing hole 310a, the injection needle 191 can pass through the space. In comparison with fig. 14, the body fixing part 350 is formed at the inner center with a fixing hole 350a, and the fixing hole 350a may include a sealing part 360. A body sealing portion 353 formed by a screw thread may be formed at a side of the body fixing portion 350 so as to be fastened to the inside of the body 310. In contrast to the drug infusion device 100 of fig. 1, the injection needle 191 can be inserted in only one direction by the drug infusion device 300. The injection needle 191 may be inserted into the seal receiving hole 310a after passing through the fixing hole 350a and passing through the sealing part 360. Thus, the medicine injection device 300 according to the third embodiment of the present invention has a simple structure, and can be easily replaced by simply fastening or detaching the body fixing portion 350 when replacing the sealing portion 360. In addition, the time required for setting and separating removal can be reduced.
Fig. 16 is a front view showing a drug infusion device according to a fourth embodiment of the present invention.
Referring to fig. 16, a drug infusion device 400 according to a fourth embodiment of the present invention may include a body 410, a movable portion 430, a body fixing portion 450, a sealing portion 460, and a movable cover portion 480. The body 410 may be formed with a movable receiving hole 410a having a hollow interior and receiving the movable portion 430. Further, the inner lower end of the body 410 may be formed with a needle insertion hole 410b connected to the movable receiving hole 410a and into which the injection needle 191 is inserted. Also, the body 410 may include an insertion portion 413 inserted into the skull bone 1 and a support portion 415 placed at an upper portion of the skull bone 1. At least two fastening connection holes 410c may be formed at the support portion 415. In contrast to the drug infusion device 100 of fig. 1, since the movable portion 430 can rotate to the left and right with respect to the center axis CL, the injection needle 191 can be guided in the direction of the target point 7, similarly to the case where a hole is formed therein. Accordingly, the sealing part 460 is accommodated between the movable part 430 and the movable cover part 480 and is doubly blocked from the outside, so that it is possible to prevent the infection by external contaminants, and the body fixing part 450 is formed with a fixing hole 450a for injecting the medicine to the center, similarly.
In contrast, the difference from fig. 1 is that the movable portion 430 is formed in a hemispherical shape, is fastened to face the movable cover portion 480, has a complete spherical shape, and is rotatable to the left and right with respect to the center axis CL. Further, the body fixing part 450 may be formed with second fastening connection holes 450b at least two points, and may be disposed in a form facing the fastening connection holes 410c of the body 410. Thus, the coupling between the body 410 and the body fixing part 450 has at least 3 points, and the fastening connection member 170 can be fastened.
The above-described embodiments are merely examples, and a person having ordinary skill in the art to which the present invention pertains may implement various modifications and equivalent embodiments. Accordingly, the true technical scope of the present invention should be determined only by the technical ideas of the invention described in the claims.
Claims (28)
1. A drug infusion device for implantation between the skull and scalp of a patient and for infusion of a drug, comprising:
a body connected to the skull and fixed by implantation, wherein a movable accommodation hole is formed inside;
a body fixing part formed with an inner hole adjacent to the body to be combined and fixed in a manner of facing the body and fastened;
A movable part located between the body and the body fixing part, and having a medicine injection hole formed at the center, capable of switching the direction to a target place;
a sealing part provided in a form of sealing the medicine injection hole of the movable part for insertion of an injection needle for injecting medicine;
a movable cover part which is positioned at the upper part of the sealing part, seals and fixes the movable part, blocks the sealing part in a form of preventing the sealing part from separating from the outside, identifies the implantation position of the drug injection device, and guides the repeated application place; and
at least two fastening connection parts for fastening the upper parts of the body and the body fixing part to the skull bone,
the body comprises a supporting part which is positioned at the upper part of the skull and is used for supporting,
the outer diameter of the supporting part is smaller than the outer diameter of the fixed part of the body and larger than the outer diameter of the movable part,
and is combined with the body fixing part in a mode of being adjacent to the body fixing part, so that the movable part is accommodated and fixed in the inner hole of the body.
2. The drug infusion device of claim 1, wherein,
the body further includes an insertion portion inserted into the cranium,
at least any one of the following conditional expression 1 and conditional expression 2 is satisfied,
< condition 1>
1＜D 1 /D 2 ≤3
< conditional 2>
2≤L 1 ≤7[mm]
Here, D 1 Is the outer diameter of the insertion part, D 2 Is the inner diameter of the movable accommodation hole, L 1 Is the insertion depth of the insertion portion.
3. The drug infusion device of claim 1, wherein,
the supporting part is located body upper portion, includes:
at least one first fastening connection hole for fixing in a form in which the fastening connection part is inserted and prevented from moving; and
at least one fixing protrusion which is fixed in a form of being combined with the body fixing part,
the following condition 3 is satisfied,
< conditional 3>
12≤D 3 /L 2 ≤60
Here, D 3 Is the outer diameter of the supporting part, L 2 Is the height of the support.
4. A drug infusion device as in claim 3, wherein,
the fixing protrusion satisfies the following condition 4,
< conditional 4>
0.3≤D 4 /L 3 ≤5
Here, D 4 Is the outer diameter of the fixing protrusion, L 3 Is the height of the fixing protrusion.
5. The drug infusion device of claim 1, wherein,
in the fixing part of the body, the fixing part is provided with a plurality of fixing parts,
a fixing hole is formed in the center, which fixes the outside in a manner of preventing the movable part from moving,
at least one second fastening connection hole is formed at the upper circumference, which is fixed in a form in which the fastening connection part is inserted and prevented from moving,
The fixing hole and the body fixing part satisfy the following condition 5 and/or the height of the body fixing part is at least any one of 1mm to 9mm,
< conditional 5>
1＜D 6 /D 5 ≤7.5
Here, D 5 Is the outer diameter of the fixed hole, D 6 Is the outer diameter dimension of the body fixing part.
6. The drug infusion device of claim 5, wherein,
the body fixing part includes:
a recognition part, the upper part of which protrudes in a curved surface form, and can be recognized; and
the lower part of the supporting and combining groove is concavely formed in a curved surface form, is consistent with the shape of the supporting part of the body, is easy to combine,
the support coupling groove is formed with at least one protrusion receiving groove coupled in a form of facing the body and a head receiving groove,
the following condition 6 is satisfied,
< conditional 6>
5＜R1≤15[mm]
Here, R is 1 Indicating the radius of the support coupling groove.
7. The drug infusion device of claim 1, wherein,
the movable part includes:
a movable body part which is positioned in the movable accommodating hole, has a curved shape and can change the direction,
the movable body portion is formed with a medicine injection hole whose inside is hollow at the center and guides medicine injection to a target site.
8. The drug infusion device of claim 1, wherein,
The movable part includes:
a medicine injection hole formed with an inner hole for injecting medicine into the cranium,
the movable portion satisfies the following condition 7,
< conditional 7>
0.4≤D 8 /L 5 ≤20
Here, D 8 Is the outer diameter of the movable part, L 5 Is the height of the movable part.
9. The drug infusion device of claim 8, wherein the device further comprises a drug delivery device,
the movable portion is formed in a spherical shape composed of sphericity of less than 0.03 mm.
10. The drug infusion device of claim 8, wherein the device further comprises a drug delivery device,
the medicine injection hole includes:
a first housing portion for housing a seal portion located in the inner hole of the movable portion; and
a second housing part connected to the first housing part and located at the lower end of the inside of the movable part for housing the injection needle inserted during injection of the medicine,
the first accommodation portion and the second accommodation portion respectively satisfy at least any one of the following conditional expressions 8 and 9,
< conditional 8>
55≤V 1 ≤80[mm 3 ]
< conditional 9>
0.5≤D 9 ≤2[mm]
Here, V 1 Is the volume of the inner space of the first accommodating part, D 9 Is the inner diameter of the second receiving portion.
11. The drug infusion device of claim 10, wherein the device further comprises a drug delivery device,
the side surface of the first housing part is formed as a screw thread from the start point of the inner hole of the movable part to the position of the housing sealing part,
The height at which the thread is formed satisfies the following condition 10,
< conditional 10>
0.2≤L 5a /L 5 ≤0.7
Here, L 5 L represents the overall height of the first and second housing portions 5a Indicating the height at which the thread is formed.
12. The drug infusion device of claim 1, wherein,
the sealing part and the movable cover part satisfy at least one of the following conditional expressions 11 and 12,
< conditional 11>
1＜D 11 /D 10 ≤7.2
< conditional 12>
0.4≤L 7 /L 6 ≤20
Here, D 10 Is the outer diameter of the sealing part, D 11 Is the outer diameter of the movable cover part, L 6 Is the height of the sealing part, L 7 Is the height of the movable cover.
13. The drug infusion device of claim 12, wherein the device further comprises a drug delivery device,
the sealing portion is composed of a silicone material.
14. The drug infusion device of claim 1, wherein,
the movable cover part includes:
the injection needle accommodating part is provided with a hole for injecting the injection needle at the center;
a position indication part, the inside of which comprises an injection needle containing part and is positioned outside the movable part;
and a movable fastening connection member connected to the position indication portion, the movable fastening connection member having a thread formed on an outer portion thereof and being fastened to the medicine injection hole by the thread constituting the male and female members.
15. The drug infusion device of claim 14, wherein the device further comprises a drug delivery device,
The needle housing portion satisfies the following condition 13,
< conditional 13>
A 1 ≥A 2
Here, A 1 An angle of an upper end of the needle housing portion, which is an angle formed to be left or right with respect to the central axis, A 2 The angle of the middle portion of the needle housing is shown.
16. The drug infusion device of claim 14, wherein the device further comprises a drug delivery device,
the position indication portion satisfies the following condition 14,
< conditional 14>
0.4≤L 7a /L 7 ＜1
Here, L 7 Indicating the overall height of the movable cover, L 7a The height of the position indication part is indicated.
17. The drug infusion device of claim 1, wherein,
the fastening connection part includes:
a main body part vertically fixed in the skull; and
a head part which is connected with the main body part,
the main body and the head satisfy at least one of the following conditional expressions 15 and 16,
< conditional 15>
1＜D 12 /D 11 ≤50
< conditional 16>
1＜L 9 /L 8 ≤100
Here, D 11 Represents the outer diameter dimension of the main body part, D 12 Representing the outer diameter dimension of the head, L 9 Indicating the length of the main body, L 8 Representing the length of the head.
18. The drug infusion device of claim 17, wherein the device further comprises a drug delivery device,
the head comprises:
a horizontal groove which is positioned at the center and is fastened and connected with a fastening and connecting tool horizontally during fastening and connecting; and
A recognition groove which is formed in a line shape divided into a horizontal axis and a vertical axis based on the horizontal groove and can be recognized,
the horizontal groove and the identification groove satisfy the following condition 17,
< conditional 17>
0.06≤D 13 /L 8a ≤12
Here, L 8a Representing the depth of the identification groove D 13 The outside diameter dimension of the horizontal groove is indicated.
19. The drug infusion device of claim 17, wherein the device further comprises a drug delivery device,
the main body part is vertically fixed in the skull, and the thread is formed in a conical form until the tail end,
at least one decompression groove satisfying the following conditional expression 18 is formed,
< conditional 18>
1＜L 9 /L 9a ≤50
Here, L 9 Indicating the length of the main body, L 9a The length of the portion where the decompression groove is formed is shown.
20. The drug infusion device of claim 1, further comprising:
and a guide tube connected to the movable portion, inserted into the ventricle and positioned close to the target, and guiding an injection needle for injecting a drug into the target site in the target direction.
21. The drug infusion device of claim 20, wherein the device further comprises a drug delivery device,
the guide tube further comprises:
and a tube connecting part arranged at the lower end of the medicine injection hole and connected between the movable part and the guide tube, wherein a hole connected with the inside of the guide tube is formed inside the tube connecting part.
22. The drug infusion device of claim 20, wherein the device further comprises a drug delivery device,
the guide tube satisfies the following condition 19,
< condition 19>
1＜D 14b /D 14a ≤3.5
Here, D 14a Represents the inner diameter dimension of the guide tube, D 14b Indicating the outside diameter dimension of the guide tube.
23. The drug infusion device of claim 20, wherein the device further comprises a drug delivery device,
the guide tube comprises a length of 10mm to 300 mm.
24. The drug infusion device of claim 21, wherein the device further comprises a drug delivery device,
the pipe connection portion satisfies at least one of the following conditional expressions 20 and 21,
< conditional 20>
1＜D 15 /D 16 ≤20
< conditional 21>
0.5≤L 10 ≤1.5[mm]
Here, D 15 Is the outer diameter of the pipe connecting part, D 16 Is the inner diameter dimension of the pipe connecting part, L 10 Is the height of the tube connection.
25. The drug infusion device of claim 20, wherein the device further comprises a drug delivery device,
the guide tube is formed with at least one medicine insertion hole so that medicine flows instead of accumulating on one side or both sides, and inner and outer diameters of the distal end of the guide tube are formed in a curve having a shape minimizing tissue damage when inserted into the cranium.
26. The drug infusion device of any one of claims 20-25, wherein,
the guide tube is rotated and deformed in the direction of the target point on the left and right sides from the central axis by a maximum angle of 60 DEG or less with reference to the surface in contact with the skull.
27. The drug infusion device of any one of claims 1-19, wherein,
at least any one of the body, the body fixing part, the movable part and the movable cover part is composed of polyether-ether-ketone,
the fastening connection member is composed of a titanium material.
28. The drug infusion device of any one of claims 20-25, wherein,
the guide tube is composed of polyether-ether-ketone.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1020200003716A KR102305032B1 (en) | 2020-01-10 | 2020-01-10 | Apparatus For Medicine Infusion |
| KR1020200003713A KR102305031B1 (en) | 2020-01-10 | 2020-01-10 | Apparatus For Medicine Infusion |
| KR10-2020-0003713 | 2020-01-10 | ||
| KR10-2020-0003716 | 2020-01-10 | ||
| PCT/KR2020/018759 WO2021141281A1 (en) | 2020-01-10 | 2020-12-21 | Drug injection device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN114945401A CN114945401A (en) | 2022-08-26 |
| CN114945401B true CN114945401B (en) | 2023-12-26 |
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ID=76787605
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202080092593.2A Active CN114945401B (en) | 2020-01-10 | 2020-12-21 | drug infusion device |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US20230045506A1 (en) |
| JP (1) | JP7473923B2 (en) |
| CN (1) | CN114945401B (en) |
| WO (1) | WO2021141281A1 (en) |
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| JP2015154874A (en) * | 2014-02-21 | 2015-08-27 | テルモ株式会社 | Insertion member fixture |
| KR20190049183A (en) * | 2017-11-01 | 2019-05-09 | 사회복지법인 삼성생명공익재단 | Apparatus for intracerebral injection of drugs and method for intracerebral injection of drugs |
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| DE19726141A1 (en) | 1997-06-19 | 1999-01-28 | Daum Gmbh | Device for inserting medical instrument into neuronal part of head |
| KR101100526B1 (en) * | 2009-06-29 | 2011-12-30 | 국립암센터 | Medicinal fluid injection port |
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- 2020-12-21 US US17/791,898 patent/US20230045506A1/en active Pending
- 2020-12-21 CN CN202080092593.2A patent/CN114945401B/en active Active
- 2020-12-21 JP JP2022542203A patent/JP7473923B2/en active Active
- 2020-12-21 WO PCT/KR2020/018759 patent/WO2021141281A1/en active Application Filing
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| US4681103A (en) * | 1985-03-11 | 1987-07-21 | Diasonics, Inc. | Ultrasound guided surgical instrument guide and method |
| US4809694A (en) * | 1987-05-19 | 1989-03-07 | Ferrara Vincent L | Biopsy guide |
| JPH11504231A (en) * | 1995-04-28 | 1999-04-20 | メドトロニック・インコーポレーテッド | Infusion catheter with bioretentive filter |
| JP2001517530A (en) * | 1997-09-16 | 2001-10-09 | エレクタ・イ・ジェ・エス・ソシエテ・アノニム | Apparatus and method for setting stereotactically and endoscopically positioned appliances |
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Also Published As
| Publication number | Publication date |
|---|---|
| JP2023519075A (en) | 2023-05-10 |
| WO2021141281A1 (en) | 2021-07-15 |
| CN114945401A (en) | 2022-08-26 |
| US20230045506A1 (en) | 2023-02-09 |
| JP7473923B2 (en) | 2024-04-24 |
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